Cipla USA recalls Lanreotide injection due to potential lack of sterility in manufacturing. Products with specific NDC numbers and expiration dates are affected. Consumers should check their product details and contact Cipla for guidance.
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Cipla USA has recalled Lanreotide injection products because of a lack of assurance of sterility during manufacturing. This could lead to contamination and potential health risks if the product is used.
The recall is due to an FDA observation that the contract manufacturing site had deficiencies in their visual inspection procedure. This could result in the product not being sterile, which might cause infections or other health issues if used.
People who have been prescribed Lanreotide injection by a doctor and are using the recalled products. Those with the specific NDC numbers and expiration dates listed in the recall are most at risk.
Check the product label for the NDC number: 69097-870-67 or the lot numbers listed (e.g., 4401666IR1) with expiration dates up to 8/31/2027 or later. The product is a single-dose injection with a pre-filled syringe and safety needle.
Look for the NDC number and expiration date on the product label to confirm if it's in the recalled list.
The FDA observed deficiencies in the visual inspection procedure at the contract manufacturing site, which could lead to a lack of sterility in the product.
Check the product label for the NDC number and expiration date. If it matches the recalled list, contact Cipla USA for further instructions.
The recall record does not specify a remedy, so consumers should check with Cipla USA for guidance.
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-0422-2026 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-0422-2026 from Cipla. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
